UnknownPhase 2/3

The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements

United States300 participantsStarted 2014-08

Plain-language summary

1. Purpose To evaluate the use of mitomycin-C (MMC) as an intraoperative adjunct during photorefractive keratectomy (PRK), its effect on postoperative healing and its ability to reduce the postoperative topical steroid course after the surgery. 2. Research Design This is a single-center, prospective, comparative cohort study. 3. Hypothesis There will not be a significant difference in the refractive corrections amongst the treatment groups, 12 months after surgery. 4. Objectives The primary study objective is to compare the effect of intraoperative MMC and a postoperative short topical steroid taper of 3 weeks, intraoperative MMC and a rapid topical steroid taper of 1 week, and a more commonly accepted postoperative regimen of a 2 month long topical steroid taper without any intraoperative MMC. The primary endpoint evaluated will be objective estimates of refractive error (WaveScan WaveFront™ System) at 12 months post-surgery. Secondarily, the extent of haze formation will be evaluated objectively using densitometry maps generated by automated Scheimpflug imaging of the cornea (Pentacam®). Furthermore, the subjective vision from the patients' perspective will be evaluated by questionnaires.

Who can participate

Age range21 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Active duty male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 is intended to ensure documentation of refractive stability.
✓. Manifest spherical equivalent (MSE) from +3.00 D to -11.0D with refractive cylinder of up to 3.00 D.
✓. Best spectacle corrected visual acuity of 20/25 or better in both eyes.
✓. Stable spectacle refraction, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50 D during the six-month period immediately preceding the baseline examination for myopic patients and 0.75 for hyperopic patients.
✓. Contact lens use: Soft contact lenses must have been removed at least two (2) weeks prior to baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four (4) weeks prior to baseline measurements.
✓. Strong motivation for attending the follow-up visits and orders to remain in the area for the duration of at least twelve months of follow up.
✓. Consent of the subject's command to participate in the study.
✓. Access to transportation to meet follow up requirements.

What they're measuring

Refractive Error

Timeframe: 12 months

Trial details

NCT IDNCT02030990

SponsorUnited States Naval Medical Center, San Diego

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-01

View on ClinicalTrials.gov More Corneal Opacity trials

Plain-language summary

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Active duty male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 is intended to ensure documentation of refractive stability.
✓. Manifest spherical equivalent (MSE) from +3.00 D to -11.0D with refractive cylinder of up to 3.00 D.
✓. Best spectacle corrected visual acuity of 20/25 or better in both eyes.
✓. Stable spectacle refraction, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50 D during the six-month period immediately preceding the baseline examination for myopic patients and 0.75 for hyperopic patients.
✓. Contact lens use: Soft contact lenses must have been removed at least two (2) weeks prior to baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four (4) weeks prior to baseline measurements.
✓. Strong motivation for attending the follow-up visits and orders to remain in the area for the duration of at least twelve months of follow up.
✓. Consent of the subject's command to participate in the study.
✓. Access to transportation to meet follow up requirements.

The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria